study of gs-0189 (formerly fsi-189) as monotherapy and in combination with rituximab in participants with relapsed/refractory non-hodgkin lymphoma

Conditions: Non-hodgkin Lymphoma

Summary: the primary objective of this study is to determine the safety and tolerability of gs-0189 (formerly fsi-189) as monotherapy and in combination with rituximab in participants with relapsed/refractory (r/r) non-hodgkin lymphoma (nhl).

the study will consist of 5 parts: 1) an initial monotherapy dose escalation (mde) part, 2) a combination dose escalation (cde) part, 3) a pharmacokinetic (pk) evaluation part, 4) an alternate schedule evaluation (ase) part and 5) a diffuse large b-cell lymphoma (dlbcl) expansion part.

Eligibility criteria:
key inclusion criteria: * dlbcl, follicular lymphoma (fl), mantle cell lymphoma (mcl), or marginal zone lymphoma (mzl) relapsed/refractory (r/r) to at least 2 prior lines of therapy. prior autologous hematopoietic cell transplantation and individuals with transformed lymphomas are permitted. individuals must be at least 3 months out from prior autologous hematopoietic cell transplantation. individuals with indolent lymphomas must be candidates for systemic treatment in the judgment of the treating physician. * in the dlbcl expansion part: dlbcl that is relapsed or refractory to at least 2 prior lines of therapy. prior autologous hematopoietic cell transplantation and individuals with transformed lymphomas are permitted. * eastern cooperative oncology group (ecog) score of 0 to 2. * for the dlbcl expansion cohort, disease must be measurable for response per lugano criteria. for all other cohorts, disease must be measurable or assessable for response per lugano criteria. * exhibit acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests. key exclusion criteria: * individuals with active brain metastases (individuals with stable treated central nervous system (cns) lesions who are off corticosteroid therapy for at least 3 weeks are not considered active. * individuals with burkitt's lymphoma. * prior treatment with a chimeric antigen receptor (car) t-cell therapy ≤ 90 days from first dose of study drug. * prior allogeneic stem cell transplant. * previous anticancer therapy including chemotherapy, hormonal therapy, and investigational agents within 3 weeks or at least 4 half-lives (up to a maximum of 4 weeks), whichever is longer, prior to first dose of study drug. * known active or chronic hepatitis b or c infection or human immunodeficiency virus. * prior treatment with cd47 or signal regulatory protein alpha (sirpα)-targeting agents. * hypersensitivity to the active substance, to murine proteins, or to any of the other excipients of rituximab * significant medical diseases or conditions, as assessed by the investigator and sponsor, that would substantially increase the risk:benefit ratio of participating in the study. * rituximab-containing cohorts only: receipt of live/attenuated vaccines within 30 days of rituximab dosing * has persisting toxicity related to prior therapy of grade \> 1 in severity per national cancer institute common terminology criteria for adverse events (nci ctcae), version 5.0. note: other protocol defined inclusion/exclusion criteria may apply.